Recall Z-3197-2026 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Howmedica Osteonics Corp.
ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA 73-0110 73-0710 73-0910 SCORPIO RECESSED PATELLA 26MM 3044-0026 SCORPIO TS TIB INS 72-4-9114 SCORPIO TS TIBIAL INSERT 72-4-032
| Date | Sep 16, 2026 (initiated Jul 30, 2026) |
| Status | Open, Classified |
| Reason | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation. |
| Root cause | Process change control |
| Action | Firm began notifying customers on July 30, 2026, via FedEx 2-day air. Customers were instructed to quarantine and discontinue use of the affected product. Affected product should be returned to the firm. |
| Quantity | 12,156 US |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpi Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Feb 6, 2025 |